Hearing DisordersNCT05644106
Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
A study testing personal sound amplification product, hearing aid in people with Hearing Disorders, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hearing Disorders
- What is being tested?
- personal sound amplification product, hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2021to 9 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 20 who speak Korean as their mother tongue and have no mental or physical limitations in conducting test.
- Hearing loss patients with a hearing threshold of 26 dB or higher in the four frequency (0.5, 1, 2, 4 kHz)
- Those who do not have a history of neurological disease, cognitive disorder, learning disorder, or language disorder at the time of recruitment
Who cannot join
- In case that communication is difficult, equipment cannot be handled, or it is difficult to cooperate with the inspection
- Acoustic nerve lesions or central nervous system disease
- Those suspected of having false hearing loss
- Those who have secondary benefits related to clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Moo Kyun Park, M.D., Ph.D., +82-2-2072-2446, entpmk@gmail.com
About this study
Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. For sensorineural hearing loss patients, who are subject to wearing hearing aids, it aims to compare the effect of hearing aid application and personal sound amplification product (PSAPs) compared to the hearing aids
- Conditions
- Hearing Disorders
- Being tested
- personal sound amplification product, hearing aid
- Keywords
- Hearing aid, Personal sound amplification product, Hearing aid application, Hearing loss
- Medical subject headings
- Hearing Disorders, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personal sound amplification product, hearing aidDevice
the device for hearing gain in sensorineural hearing loss
| Study group | Role | What they receive |
|---|---|---|
| Unaided | Active comparator | Not described Receives: Device: personal sound amplification product, hearing aid |
| Aided | Active comparator | Not described Receives: Device: personal sound amplification product, hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hearing level threshold (decibel) after each treatment
The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start10 Aug 2021
- Primary completion10 Sep 2021
- Study completion9 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing DisordersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moo Kyun, Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644106
- Sponsor's protocol ID
- 2105-200-1223
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jo S, Park MK, Seo JH, Lee KE, Han JS, Lim JH, Lee JH, Oh SH. Feasibility of a Smartphone-Based Hearing Aid App for Mild-to-Moderate Hearing Loss: Prospective Multicenter Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 5;11:e46911. doi: 10.2196/46911.
PubMed 37800887
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
- ClinicalTrials.gov ID
- NCT05644106
- Acronym / sponsor ID
- 2105-200-1223
- Conditions
- Hearing Disorders
- Keywords
- Hearing aid, Personal sound amplification product, Hearing aid application, Hearing loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 9 Aug 2023 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. For sensorineural hearing loss patients, who are subject to wearing hearing aids, it aims to compare the effect of hearing aid application and personal sound amplification product (PSAPs) compared to the hearing aids
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unaided | Active comparator | Device: personal sound amplification product, hearing aid |
| Aided | Active comparator | Device: personal sound amplification product, hearing aid |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over the age of 20 who speak Korean as their mother tongue and have no mental or physical limitations in conducting test.
- Hearing loss patients with a hearing threshold of 26 dB or higher in the four frequency (0.5, 1, 2, 4 kHz)
- Those who do not have a history of neurological disease, cognitive disorder, learning disorder, or language disorder at the time of recruitment
Key exclusion criteria (4 listed)
- In case that communication is difficult, equipment cannot be handled, or it is difficult to cooperate with the inspection
- Acoustic nerve lesions or central nervous system disease
- Those suspected of having false hearing loss
- Those who have secondary benefits related to clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personal sound amplification product, hearing aidthe device for hearing gain in sensorineural hearing loss | Device | Aided, Unaided |
Primary outcome
The hearing level threshold (decibel) after each treatment
Time frame: 1 month
The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Derived from this study: PubMed 37800887Jo S, Park MK, Seo JH, Lee KE, Han JS, Lim JH, Lee JH, Oh SH. Feasibility of a Smartphone-Based Hearing Aid App for Mild-to-Moderate Hearing Loss: Prospective Multicenter Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 5;11:e46911. doi: 10.2196/46911.
Related trials for Hearing Disorders
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personal sound amplification product, hearing aid in people with Hearing Disorders, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moo Kyun Park, M.D., Ph.D. (+82-2-2072-2446, entpmk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The hearing level threshold (decibel) after each treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.